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Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers (MB)

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ClinicalTrials.gov Identifier: NCT00777361
Recruitment Status : Terminated
First Posted : October 22, 2008
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Last Update Posted Date November 18, 2010
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
  • Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio. [ Time Frame: Urine and faeces collection for at least 168 hours (up to 2 weeks)9 (blood) and 17 (plasma) samples during 48 and 72 hours. ]
  • Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss) [ Time Frame: 19 and 18 blood samples during 72 and 96 hours after iv (Visit 2) and po dosing (Visit 3) respectively. Urine collection for 72 hours and 168 hours (up to 2 weeks). ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
  • identity of major metabolites in plasma and excreta [ Time Frame: 4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks). ]
  • Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis. [ Time Frame: From enrollment to follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
  • identity of major metabolites in plasma and excreta [ Time Frame: 4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks). ]
  • Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, haematology, clinical chemisty and urinalysis. [ Time Frame: From enrollment to follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
Official Title  ICMJE An Open, Two Period, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following Oral Administration of [14C]-AZD3480 and the Pharmacokinetics of AZD3480 Following Intravenous Administration to Healthy Male Volunteers With Different CYP2D6 Genotype
Brief Summary This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: AZD3480
    Iv single dose, 4-hour infusion of 25 mg
  • Drug: AZD3480
    Oral solution single dose of 50 mg
Study Arms  ICMJE
  • Experimental: AZD3480 iv
    Single iv infusion AZD3480
    Intervention: Drug: AZD3480
  • Experimental: Oral [14C] AZD3480
    Single oral dose [14C]AZD3480
    Intervention: Drug: AZD3480
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 15, 2010)
9
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
12
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Physically healthy volunteers
  • Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)

Exclusion Criteria:

  • History of clinically significant diseases or illness.
  • Ues of any prescribed or non-prescribed medications from 2 weeks prior to first treatment day except for paracetamol and OTC adrenergic nasal spray.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777361
Other Study ID Numbers  ICMJE D3690C00017
EudraCT No.: 2007-005903-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Björn Paulsson, MD, PhD, Medical Science Director Clinical Neuroscience TA, AstraZeneca R&D Södertälje
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Björn Paulsson, MD, PhD AstraZeneca Södertälje, Sweden
Principal Investigator: Tim Mant, Prof Quintiles Drug Research Unit @ Guy´s Hospital
PRS Account AstraZeneca
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP